Effects of Mechanical Ventilation on the Diaphragm in COVID-19 Intensive Care Patients. A Post-mortem Pathology Study

NCT05191433 | Unknown

• 1 other identifier: COVID DIAPHRAGM
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

The diaphragm is the fundamental muscle of the respiratory system. The diaphragmatic dysfunction is present in 60% of critical patients at hospital admission and up to 80% after prolonged mechanical ventilation and difficult weaning. Risk factors associated with diaphragm dysfunction and atrophy are sepsis, trauma, sedatives, steroids, and muscle relaxants. The main pathology characteristics of diaphragm biopsies of mechanically ventilated patients are atrophy and a reduction in contractility, determining an impact on the clinical outcome. Shi et al. found a higher section area of the diaphragm muscle fiber in biopsies of post mortem COVID-19 patients versus negative patients, independently from days of mechanical ventilation. The hypothesis of our study is to identify different clusters of pathological presentation in post-mortem COVID-19 mechanically ventilated patients.

Conditions

Diaphragm Injury; Pathology; COVID-19 Acute Respiratory Distress Syndrome; Ventilation Therapy; Complications

Outcome Measures

Primary Outcomes (3)

• Clinical characteristics

  Evaluate if there are specific clusters in the study population and find different clinical characteristics.

  One week post mortem

• Blood test characteristics

  Evaluate if there are specific clusters in the study population and find different blood test characteristics.

  One week post mortem

• Pathology characteristics

  Evaluate if there are specific clusters in the study population and find different pathology characteristics.

  One week post mortem

Secondary Outcomes (3)

• Mechanical ventilation

  One week post mortem

• Therapy

  One week post mortem

• Arterial blood gas analysis

  One week post mortem

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Deceased COVID-19 patients admitted to the intensive care unit and mechanically ventilated.

You may qualify if:

• patients deceased in the intensive care unit positive to SARS-CoV-2 and mechanically ventilated
• post-mortem examination of the diaphragm

You may not qualify if:

• patients with a terminal disease and a prognosis of less than 48 hours at admission.

Sponsors & Collaborators

• Azienda Sanitaria-Universitaria Integrata di Udine: lead

Study Sites (2)

Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD

Udine, 33100, Italy

RECRUITING

Azienda ospedaliero universitaria Friuli Centrale, Clinica di Anestesia e Rianimazione

Udine, Italy

RECRUITING

Related Publications (6)

• McCool FD, Manzoor K, Minami T. Disorders of the Diaphragm. Clin Chest Med. 2018 Jun;39(2):345-360. doi: 10.1016/j.ccm.2018.01.012.

  PMID: 29779594 BACKGROUND

• Supinski GS, Morris PE, Dhar S, Callahan LA. Diaphragm Dysfunction in Critical Illness. Chest. 2018 Apr;153(4):1040-1051. doi: 10.1016/j.chest.2017.08.1157. Epub 2017 Sep 5.

  PMID: 28887062 BACKGROUND

• Dres M, Goligher EC, Heunks LMA, Brochard LJ. Critical illness-associated diaphragm weakness. Intensive Care Med. 2017 Oct;43(10):1441-1452. doi: 10.1007/s00134-017-4928-4. Epub 2017 Sep 15.

  PMID: 28917004 BACKGROUND

• Goligher EC, Dres M, Fan E, Rubenfeld GD, Scales DC, Herridge MS, Vorona S, Sklar MC, Rittayamai N, Lanys A, Murray A, Brace D, Urrea C, Reid WD, Tomlinson G, Slutsky AS, Kavanagh BP, Brochard LJ, Ferguson ND. Mechanical Ventilation-induced Diaphragm Atrophy Strongly Impacts Clinical Outcomes. Am J Respir Crit Care Med. 2018 Jan 15;197(2):204-213. doi: 10.1164/rccm.201703-0536OC.

  PMID: 28930478 BACKGROUND

• Hooijman PE, Beishuizen A, Witt CC, de Waard MC, Girbes AR, Spoelstra-de Man AM, Niessen HW, Manders E, van Hees HW, van den Brom CE, Silderhuis V, Lawlor MW, Labeit S, Stienen GJ, Hartemink KJ, Paul MA, Heunks LM, Ottenheijm CA. Diaphragm muscle fiber weakness and ubiquitin-proteasome activation in critically ill patients. Am J Respir Crit Care Med. 2015 May 15;191(10):1126-38. doi: 10.1164/rccm.201412-2214OC.

  PMID: 25760684 BACKGROUND

• Shi Z, Bogaards SJP, Conijn S, Onderwater Y, Espinosa P, Bink DI, van den Berg M, van de Locht M, Bugiani M, van der Hoeven H, Boon RA, Heunks L, Ottenheijm CAC. COVID-19 is associated with distinct myopathic features in the diaphragm of critically ill patients. BMJ Open Respir Res. 2021 Sep;8(1):e001052. doi: 10.1136/bmjresp-2021-001052.

  PMID: 34544735 BACKGROUND

Central Study Contacts

Luigi Vetrugno, MD

CONTACT

+ 39 0432559509; luigi.vetrugno@asufc.sanita.fvg.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Anesthesia and Intensive Care

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 13, 2022
• Study Start: November 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: January 20, 2022
• Last Updated: January 13, 2022

Record last verified: 2022-01

Locations

IT (2)